Liposuction device and use thereof

ABSTRACT

Embodiments of the present invention disclose a device for removing adipose tissue, comprising a self-contained syringe device comprising an inner syringe included within an outer syringe and wherein a filter is attached inside the outer syringe barrel; wherein the filter comprises a filter material that prevents premature filter collapse where the filter material is optionally coated to increase stiffness, and wherein liposuctioned adipose tissue is collected and purified inside the syringes. Methods of using the devices or system are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Continuation-In-Part of U.S. patent applicationSer. No. 15/199,773 filed on Jun. 30, 2016, which claims the benefit ofU.S. Provisional Patent Application No. 62/207,746 filed Aug. 20, 2015.The teaching of these prior applications are incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

The invention relates generally to biomedical sciences and technologiesand particularly to tissue harvesting and tissue graft applicationdevices and methods.

BACKGROUND OF THE INVENTION

The transfer of adipose tissue to various regions of the body is arelatively common cosmetic, therapeutic and structural procedureinvolving the harvest of adipose tissue from one location andre-implantation of the harvested and, oftentimes processed tissue, inanother location (see Coleman 1995; and Coleman 2001). While beinglargely used for repair of small cosmetic defects such as facial folds,wrinkles, pock marks and divots; the transfer of adipose tissue hasrecently been used for cosmetic and/or therapeutic breast augmentationand reconstruction (Bircoll and Novack 1987; and Dixon 1988), andaugmentation of the buttocks (Cardenas-Camarena, Lacouture et al. 1999;de Pedroza 2000; and Peren, Gomez et al. 2000).

In the past, adipose tissue grafts and methods of adipose tissuetransfer have been plagued with difficulties and side effects includingnecrosis, absorption of the implant by the body, infection (Castello,Barros et al. 1999; Valdatta, Thione et al. 2001), calcifications andscarring (Huch, Kunzi et al. 1998), inconsistent engraftment, (Eremiaand Newman 2000), lack of durability, and other problems arising fromlack of neovascularization and necrosis of the transplanted tissue. Oneof the biggest challenges in adipose tissue transfer is absorption ofthe implant by the body and volume retention of adipose tissue graftsfollowing transfer. When adipose tissue is harvested or washed, thespace between individual pieces of harvested adipose tissue is filled byliquid (e.g., water, blood, tumescent solution, oil). When thistissue/fluid mixture is implanted into a recipient the liquid portion israpidly absorbed by the body resulting in loss of volume. The process bywhich the amount of fluid is removed from the tissue/fluid mixture isfrequently referred to as “drying the adipose tissue” or “dehydratingthe adipose tissue”. The content of red and white blood cells and thelike within an adipose tissue graft can also significantly affect thevolume of graft retained after graft transplantation, due to inductionor exacerbation of an inflammatory response. Another aspect of tissueretention relates to the amount of lipid within the adipose tissuegraft. It understood that the presence of free lipid (meaning lipidsreleased from dead or damaged adipocytes; also referred to as oil) inadipose tissue grafts can result in induction or exacerbation of aninflammatory response with substantial phagocytic activity andconsequent loss of graft volume.

It is also known that mixing unprocessed adipose tissue with aconcentrated population of adipose-derived regenerative cells overcomesmany of the problems associated with adipose tissue grafts and adiposetissue transfer, as described above. Specifically, supplementingunprocessed adipose tissue with concentrated populations ofadipose-derived cells comprising adipose-derived stem cells increasesthe weight, vascularization, and retention of fat grafts. (See U.S. Pat.No. 7,390,484 and co-pending U.S. Patent Application Publication No.2005/0025755, issued on Jan. 26, 2010 as U.S. Pat. No. 7,651,684, hereinexpressly incorporated by reference in their entireties). Adipose tissuefragments supplemented, or mixed, with a concentrated population ofcells including adipose-derived stem cells exhibit improvedneoangiogeneis and perfusion in grafts when compared to unsupplementedgrafts of adipose tissue alone in animal models. Further, adipose tissuegrafts supplemented with adipose-derived regenerative cells thatcomprise adipose derived stem cells show increased graft retention andweight over time, when compared to unsupplemented grafts. (See U.S.Patent Application Publication No. 2005/0025755, issued on Jan. 26, 2010as U.S. Pat. No. 7,651,684). Further, the processing of adipose tissuein a closed, sterile fluid pathway greatly reduces the chance ofinfection. The improvement in autologous transfer of adipose tissue seenin the animal models described above has also been replicated in humanclinical studies. Nevertheless, the isolation and purification ofconcentrated populations of adipose-derived regenerative cellscomprising adipose-derived stem cells (ADSCs), usually involves a seriesof washing, digestion, filtration and/or centrifugation steps, which canreduce the yield of viable cells, require mechanical equipment andspecialized clinicians, and/or can compromise the quality, appearance,longevity, hydration or efficacy of the graft.

Additionally, stresses could cause undesirable reactions to harvestedadipose tissues. Such stresses include, for example, exposure toenvironmental pathogens, which are mentioned above, and prolongedpost-harvest storage, etc. Therefore, there is a need for in-situharvest, cleaning, and use of an adipose tissue graft for biomedicalapplications.

The need for additional approaches to prepare and optimize adiposetissue grafts and implants and to isolate and/or concentrateadipose-derived regenerative cells is manifest.

SUMMARY OF THE INVENTION

In one aspect of the present invention, it is provided an adipose tissuecollection and purification device comprising a self-contained syringedevice comprising an inner syringe included within an outer syringe,

-   -   wherein a filter or a series of filters (e.g., a 2 stage or 3        stage filter) is attached inside the outer syringe barrel,    -   wherein the filter comprises a filter material, and    -   wherein lipoaspirated adipose tissue is collected and purified        inside the syringes.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the filter comprises a filtermaterial that is coated so as to increase stiffness and preventpremature filter collapse.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the filter has a mesh pore sizebetween 30 micro meters and 3000 micro meters, e.g., 1200 micro metersor 2500 micro meters.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe containedwithin the outer syringe is able to evacuate the waste product fromlipoaspirated tissue into its barrel and remain contained within itsbarrel during the reinjection of remaining adipose contained within thefilter of the outer syringe.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe plungercontains a one-way valve that allows for the passage of lipoaspiratewaste into its barrel but does not allow the lipoaspirate waste tore-enter the barrel of the outer syringe.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is non-roundshaped with a corresponding non-round shaped piston such that the pistonis prevented from rotation while the inner syringe is being unscrewed.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that allows a waste product to evacuate from thelipoaspirated tissue into a separate waste product chamber.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is a syringeof a wash fluid for washing the tissue, while back flowing the filter toclean the filter.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that attaches to a piston with a luer-activatedport, thus self-sealing when the waste syringe is removed so as toprevent leaking and keep the device a closed system.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is added gripso as to overcome an issue of grip caused by slipperiness of the adiposetissue.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the non-round shaped syringeprovides extra grip to overcome an issue of grip caused by slipperinessof the adipose tissue.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a customlocking mechanism to allow locking in the open position, therebyallowing for holding of a vacuum.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a syringetip clogging guard added to the end of the syringe.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aneedle or a needle hub, wherein the needle or needle hub is attached tothe self-contained syringe device.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aguide that prevents the over insertion and under insertion and thusallows collection of subcutaneous adipose tissue at desired depth.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the guide is curved to allowpuncture of the needle and forces the needle to remain in thesubcutaneous layer of adipose tissue.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism that pinches the exterior of the skin and thus raises thesubcutaneous fat layer to allow for insertion of the needle.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism utilizing vacuum to raise the fat layer.

In another aspect of the present invention, it is provided a method,which method comprising collecting and purifying an adipose tissue usinga device, wherein the device comprising a self-contained syringe devicecomprising an inner syringe included within an outer syringe,

wherein a filter or a series of filters (e.g., a 2 stage or 3 stagefilter) is attached inside the outer syringe barrel,

wherein the filter comprises a filter material, and

wherein lipoaspirated adipose tissue is collected and purified insidethe syringes.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the filter comprises a filtermaterial that is coated so as to increase stiffness and preventpremature filter collapse.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the filter has a mesh pore sizebetween 30 micro meters and 3000 micro meters, e.g., 1200 micro metersor 2500 micro meters.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe containedwithin the outer syringe is able to evacuate the waste product fromlipoaspirated tissue into its barrel and remain contained within itsbarrel during the reinjection of remaining adipose contained within thefilter of the outer syringe.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe plungercontains a one-way valve that allows for the passage of lipoaspiratewaste into its barrel but does not allow the lipoaspirate waste tore-enter the barrel of the outer syringe.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is non-roundshaped with a corresponding non-round shaped piston such that the pistonis prevented from rotation while the inner syringe is being unscrewed.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that allows a waste product to evacuate from thelipoaspirated tissue into a separate waste product chamber.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is a syringeof a wash fluid for washing the tissue, while back flowing the filter toclean the filter.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that attaches to a piston with a luer-activatedport, thus self-sealing when the waste syringe is removed so as toprevent leaking and keep the device a closed system.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is added gripso as to overcome an issue of grip caused by slipperiness of the adiposetissue.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the non-round shaped syringeprovides extra grip to overcome an issue of grip caused by slipperinessof the adipose tissue.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a customlocking mechanism to allow locking in the open position, therebyallowing for holding of a vacuum.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a syringetip clogging guard added to the end of the syringe.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aneedle or a needle hub, wherein the needle or needle hub is attached tothe self-contained syringe device.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aguide that prevents the over insertion and under insertion and thusallows collection of subcutaneous adipose tissue at desired depth.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the guide is curved to allowpuncture of the needle and forces the needle to remain in thesubcutaneous layer of adipose tissue.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism that pinches the exterior of the skin and thus raises thesubcutaneous fat layer to allow for insertion of the needle.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism utilizing vacuum to raise the fat layer.

In some embodiments of the invention method, optionally in combinationwith any or all the various embodiments described herein, the subject isa human being.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 and FIG. 2 show various elements that can be used to form anembodiment device of the present invention.

FIG. 3A and FIG. 3B show an embodiment of an invention device.

FIG. 4 shows an embodiment of an invention device having an outersyringe and an inner syringe.

FIG. 5 shows an embodiment of an invention device where a volume ofcleaned fat tissue (yellow) is included in the larger outer syringe anda volume of waste in included in the inner syringe (pink).

FIG. 6 shows an invention embodiment where a clogging guard (whitecylinder) installed on syringe body at left; annular filter design (greyfoam material) installed on syringe piston assembly at right.

FIG. 7 is a close-up of interaction between clogging guard and annularfilter.

FIG. 8 shows a 60 cc syringe system of invention being used effectivelyin-lab. The clean tissue is at left; the waste fluid is in the wastesyringe at right. The luer activated valve can be seen center.

FIG. 9 shows a 60 cc CAD illustration showing square bore syringe andlocking button (teal, with ridges).

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION Definitions

As used herein, the term “adipose tissue” is used interchangeably withthe term “fat”, the meaning of which is well known to a person ofordinary skill in the art.

As used herein, the term “adipose tissue removal” or “tissue removal” or“harvesting” or “liposuction” are used interchangeably to mean remove anamount of adipose tissue from a live subject such as a male or femalepatient.

As used herein, the term “collapsible” refers to the attribute of amaterial capable of collapsing under pressure or vacuum or capable ofchanging of shape or contour or of deformation in response to pressurechange, and as such, in some embodiments, the term “collapsible” canmean deformable. An example of a material that is collapsible is aplastic or polymeric material forming a bag, e.g., a bag that isdescribed in U.S. patent application Ser. No. 12/771,985, issued on Sep.15, 2015 as U.S. Pat. No. 9,133,431, the teachings of which isincorporated herein by reference in its entirety.

As used herein, the term “filter” refers to a porous material having asize or size distribution useful for adipose tissue filtration. Someexamples of filter useful for the present invention are described inU.S. patent application Ser. No. 12/771,985, issued on Sep. 15, 2015 asU.S. Pat. No. 9,133,431, the teachings of which is incorporated hereinby reference in its entirety.

As used herein, the term “lipoaspirated” and “liposuctioned” can be usedinterchangeably.

Micro Needles

In some embodiments of the present invention, the invention device canattach to a needle or needles. In some embodiments, the needle cancomprise a needle hub that comprises at least one needle that containsbetween 1-1000 holes around the diameter of the needle barrel whichallows passage of adipose tissue and other lipoaspirate.

In some embodiments of the invention device, optionally in combinationwith any or all the various embodiments disclosed herein, the needle hubcomprises a plurality of needles each of which contains between 1-1000holes around the diameter of the needle barrel which allows passage ofadipose tissue and other lipoaspirate.

In some embodiments of the invention device, optionally in combinationwith any or all the various embodiments disclosed herein, the needlebarrel is between 10 and 32 gauge (e.g., 12 or 13 gauge) in diameter.

In some embodiments of the invention device, optionally in combinationwith any or all the various embodiments disclosed herein, the needlebarrel is between 1 mm and 200 mm in length.

In some embodiments of the invention device, optionally in combinationwith any or all the various embodiments disclosed herein, the holescontained around the diameter of the needle barrel have a geometry thatallows for the cutting and removal of lipoaspirate as the device ispushed forward and backwards within the subcutaneous space. In someembodiments, the holes contained around the diameter of the needlebarrel have a geometry that allows for the cutting and removal oflipoaspirate as the device is orated within the subcutaneous space.

In some embodiments of the invention device, optionally in combinationwith any or all the various embodiments disclosed herein, the devicefurther comprising a guide that prevents the over insertion and underinsertion and thus allows collection of subcutaneous adipose tissue atdesired depth.

In some embodiments of the invention device, optionally in combinationwith any or all the various embodiments disclosed herein, the guide iscurved to allow puncture of the needle and forces the needle to remainin the subcutaneous layer of adipose tissue.

In some embodiments of the invention device, optionally in combinationwith any or all the various embodiments disclosed herein, the guidefurther contains a mechanism that pinches the exterior of the skin andthus raises the subcutaneous fat layer to allow for insertion of theneedle. In some embodiments, the guide further contains a mechanismutilizing vacuum to raise the fat layer.

Adipose Tissue Collection and Purification

In one aspect of the present invention, it is provided an adipose tissuecollection and purification device comprising a self-contained syringedevice comprising an inner syringe included within an outer syringe,

wherein a filter or a series of filters (e.g., a 2 stage or 3 stagefilter) is attached inside the outer syringe barrel,

wherein the filter comprises a filter material, and

wherein lipoaspirated adipose tissue is collected and purified insidethe syringes.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the filter comprises a filtermaterial that is coated so as to increase stiffness and preventpremature filter collapse.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the filter has a mesh pore sizebetween 30 micro meters and 3000 micro meters, e.g., 1200 micro metersor 2500 micro meters.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe containedwithin the outer syringe is able to evacuate the waste product fromlipoaspirated tissue into its barrel and remain contained within itsbarrel during the reinjection of remaining adipose contained within thefilter of the outer syringe.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe plungercontains a one-way valve that allows for the passage of lipoaspiratewaste into its barrel but does not allow the lipoaspirate waste tore-enter the barrel of the outer syringe.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is non-roundshaped with a corresponding non-round shaped piston such that the pistonis prevented from rotation while the inner syringe is being unscrewed.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that allows a waste product to evacuate from thelipoaspirated tissue into a separate waste product chamber.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is a syringeof a wash fluid for washing the tissue, while back flowing the filter toclean the filter.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that attaches to a piston with a luer-activatedport, thus self-sealing when the waste syringe is removed so as toprevent leaking and keep the device a closed system.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is added gripso as to overcome an issue of grip caused by slipperiness of the adiposetissue.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the non-round shaped syringeprovides extra grip to overcome an issue of grip caused by slipperinessof the adipose tissue.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a customlocking mechanism to allow locking in the open position, therebyallowing for holding of a vacuum.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a syringetip clogging guard added to the end of the syringe.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aneedle or a needle hub, wherein the needle or needle hub is attached tothe self-contained syringe device.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aguide that prevents the over insertion and under insertion and thusallows collection of subcutaneous adipose tissue at desired depth.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the guide is curved to allowpuncture of the needle and forces the needle to remain in thesubcutaneous layer of adipose tissue.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism that pinches the exterior of the skin and thus raises thesubcutaneous fat layer to allow for insertion of the needle.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism utilizing vacuum to raise the fat layer.

An embodiment of the invention device is described in FIGS. 3A and 3B(PUREGRAFT 10 SYRINGE ASSEMBLY). Referring to FIG. 3A, element 1 is anouter syringe barrel, 2 is a piston, 3 is a locking pin, 4 is a valve(e.g., a check valve), 5 is an inner syringe, which is also referred asa female syringe, 6 is a filter component, which can be, for example, apolyester mesh (e.g., 73 micron with 40% open area), 7 is an additionalfilter component, which can be, for example, 20 PPI polyester foam, 8 isa further additional filter component, which can be, for example, 45 PPIpolyester foam, 6-8 comprising a multiple stage depth filter element ofthe invention device, and 9 is an O-ring, which can have a size of [2mm×11 mm ID], made of silicone, e.g. FIG. 3B shows the assembly of theinvention device of FIG. 3A.

Another embodiment of the invention device is described in FIG. 4.Referring to FIG. 4, the invention device embodiment includes 1, anouter syringe barrel, 4, a valve, 5, an inner syringe, 6, a filtercomponent (a mesh), 7, an additional filter component (a foam), and afurther additional filter component, 8 (a 73 micron filter disk). In oneembodiment, the specifications of the elements of the device in FIG. 4are the same as the corresponding elements of the device of FIG. 3A.

FIG. 6-FIG. 9 describe a few further embodiments of the inventionsyringes. Referring to FIG. 6, a filter is designed to have a geometryof a “annular” design, which provides the maximum surface area (seeelement 6 a in FIG. 6). The filter comprises a filter material that iscoated to increase stiffness and prevent premature filter collapse, sucha filter is stiff enough to not deform from the filtration pressure, butsoft enough to allow one to compress and squeeze out all orsubstantially all the tissue at the end of the process of invention. Insome embodiments, the filter has a mesh pore size between 30 micrometers and 3000 micro meters, e.g., 1200 micro meters or 2500 micrometers.

In some embodiments, the shape of the syringe can be non-round (i.e.square). An advantage of a syringe of a non-round shape is that itprevents piston rotation while a user unscrews the inner waste chambersyringe (see FIG. 9).

In some embodiments, the inner waste chamber of the invention syringecan be replaced with a syringe of wash fluid for washing the tissue,while back flowing the filter to clean the filter. In some embodiments,the waste chamber attaches to the piston with a luer-activated port(element 15 in FIG. 8), thus self-sealing when the waste syringe isremoved—without this feature, the syringe would leak and not be a closedsystem (FIG. 8). Because of the custom shape of the syringe, grip can beadded which could be absent on a normal syringe so as to overcome thegrip issue caused by slipperiness of the fat tissue.

In some embodiments, the syringe can have a custom locking feature thatallows locking in the open position, thus allowing for the holding ofvacuum. This design will be unique and easy to use (see FIG. 8).

In some embodiments, a syringe of invention can have a syringe tipclogging guard. Testing by inventors of the present invention revealed atendency for the final washed fat tissue to clog at the tip of a syringewhen being expelled in that the foam filter would clog the port when incontact (data not shown). To address this issue, a “clog guard” can beadded to the end of the syringe, which keeps the foam contained and addsnumerous fluid paths for the tissue to escape and be expelled (seeelement 14 in FIG. 6).

Adipose Tissue Harvesting, Collection and Purification Method

In another aspect of the present invention, it is provided a method,which method comprising collecting and purifying an adipose tissue usinga device, wherein the device comprising a self-contained syringe devicecomprising an inner syringe included within an outer syringe,

wherein a filter or a series of filters (e.g., a 2 stage or 3 stagefilter) is attached inside the outer syringe barrel,

wherein the filter comprises a filter material, and

wherein lipoaspirated adipose tissue is collected and purified insidethe syringes.

In some embodiments of the invention device, optionally in one or moreinvention embodiments disclosed herein, the filter comprises a filtermaterial that is coated so as to increase stiffness and preventpremature filter collapse.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the filter has a mesh pore sizebetween 30 micro meters and 3000 micro meters, e.g., 1200 micro metersor 2500 micro meters.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe containedwithin the outer syringe is able to evacuate the waste product fromlipoaspirated tissue into its barrel and remain contained within itsbarrel during the reinjection of remaining adipose contained within thefilter of the outer syringe.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe plungercontains a one-way valve that allows for the passage of lipoaspiratewaste into its barrel but does not allow the lipoaspirate waste tore-enter the barrel of the outer syringe.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is non-roundshaped with a corresponding non-round shaped piston such that the pistonis prevented from rotation while the inner syringe is being unscrewed.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that allows a waste product to evacuate from thelipoaspirated tissue into a separate waste product chamber.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is a syringeof a wash fluid for washing the tissue, while back flowing the filter toclean the filter.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the inner syringe is an innerwaste chamber syringe that attaches to a piston with a luer-activatedport, thus self-sealing when the waste syringe is removed so as toprevent leaking and keep the device a closed system.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the outer syringe is added gripso as to overcome an issue of grip caused by slipperiness of the adiposetissue.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the non-round shaped syringeprovides extra grip to overcome an issue of grip caused by slipperinessof the adipose tissue.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a customlocking mechanism to allow locking in the open position, therebyallowing for holding of a vacuum.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the syringe comprises a syringetip clogging guard added to the end of the syringe.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aneedle or a needle hub, wherein the needle or needle hub is attached tothe self-contained syringe device.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the device further comprises aguide that prevents the over insertion and under insertion and thusallows collection of subcutaneous adipose tissue at desired depth.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the guide is curved to allowpuncture of the needle and forces the needle to remain in thesubcutaneous layer of adipose tissue.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism that pinches the exterior of the skin and thus raises thesubcutaneous fat layer to allow for insertion of the needle.

In some embodiments of the invention method, optionally in one or moreinvention embodiments disclosed herein, the guide further contains amechanism utilizing vacuum to raise the fat layer.

FIG. 5 describes an assembled invention device embodiment of FIG. 9 inuse of tissue harvesting. As shown in FIG. 10, a volume of tissue (12)was collected and cleaned in the outer syringe (1), and the waste (13)was collected in the inner syringe (5).

The description below provides an embodiment procedure of using asyringe of invention (referred to as “PG syringe” or “syringe”).

-   -   1) Open box that contains the PG syringe, and remove the tray.        Peel back the Tyvek to reveal the sterile PG syringe.    -   2) After a patient is prepared for liposuction, insert a 2 mm        cannula (could be included in a kit) into the patient, and pull        syringe back until it locks in the vacuum position.    -   3) Liposuction the patient until syringe is full of lipoaspirate        or when a desired volume is harvested.    -   4) Point syringe up and expel air; cap syringe with included        cap. Let sit with tip up for 60 seconds.    -   5) Drain waste by pulling a vacuum on the waste syringe until        tissue is dry.    -   6) Remove waste syringe, and attach syringe with an amount of        saline: inject the saline into tissue.    -   7) Drain wash by pulling a vacuum on the waste syringe until        tissue is dry.    -   8) Tissue is ready to inject or transfer to desired injection        syringe.    -   9) Dispose of entire PG syringe when finished.

Method of Use

The adipose tissue collected and purified using the invention device canbe used in a variety of applications. Such applications (also referredto as “method of use”) includes biomedical and cosmetic applications ona subject. Cosmetic applications can be, for example, organ reshaping oraugmentation. Biomedical applications can be, for example, tissuegrafting, and cell therapy or tissue regenerative therapies.

EXAMPLES Example 1. Tissue Harvesting Via Micro Needle Liposuction

A closed adipose tissue harvesting and cleaning procedure wassuccessfully carried out using an embodiment invention device of FIG. 4.As shown in FIG. 5, a volume of tissue (12) was collected and cleaned inthe outer syringe (1), and the waste (13) was collected in the innersyringe (5). The cleaned adipose tissue 12 is ready for use.

We have successfully combined these requirements into one device thathas been used to harvest animal fat. We tested both needle cannulas withanimal fat to show that tissue could be collected without clogging ofthe cannulas. The first test was with the 16 ga needle and the tissueseparation device and was able to collect 1-2 grams in just a fewminutes. (See FIG. 6) Using animal fat (Pork Bellies) is considered aworst case test for us, in that we cannot really introduce tumescentfluid, and the tissue is at room temperature. But that we were able tocollect measurable amount of tissue in a short time was significant. Ourinitial goal is to be able to collect 5 to 10 grams of adipose tissue inless than 10 minutes. We tested using a 22 ga. needle modified with 4side ports. Again, we were able to collect measurable amount of animaltissue in a short period of time. (See FIG. 2) Comparing the two images,you can see that the 22 ga. needle is much smaller, but able to getabout the same amount of adipose tissue.

Example 2. Tissue Harvesting Using an Embodiment of Invention Device

FIG. 8 is a photo image of an embodiment of invention device withcleaned tissue (yellow) in the outer syringe and waste product in theinner syringe.

While various embodiments of the present invention have been shown anddescribed herein, it will be obvious that such embodiments are providedby way of example only. Numerous variations, changes and substitutionsmay be made without departing from the invention herein. Accordingly, itis intended that the invention be limited only by the spirit and scopeof the appended claims.

The teachings of the references, including patents and patent relateddocuments, cited herein are incorporated herein in their entirety to theextent not inconsistent with the teachings herein.

We claim:
 1. An adipose tissue collection and purification devicecomprising a self-contained syringe device comprising an inner syringeincluded within an outer syringe, wherein a filter is attached insidethe outer syringe barrel; wherein the filter comprises a filtermaterial, and wherein lipoaspirated adipose tissue is collected andpurified inside the syringes.
 2. The adipose tissue collection andpurification device of claim 1, wherein the filter having a mesh poresize between 30 micro meters and 3000 micro meters.
 3. The adiposetissue collection and purification device of claim 1, wherein the innersyringe contained within the outer syringe is able to evacuate the wasteproduct from lipoaspirated tissue into its barrel and remain containedwithin its barrel during the reinjection of remaining adipose containedwithin the filter of the outer syringe.
 4. The adipose tissue collectionand purification device of claim 1, wherein the inner syringe plungercontains a one-way valve that allows for the passage of lipoaspiratewaste into its barrel but does not allow the lipoaspirate waste tore-enter the barrel of the outer syringe.
 5. The adipose tissuecollection and purification device of claim 1, wherein the outer syringeis non-round shaped with a corresponding non-round shaped piston suchthat the piston is prevented from rotation while the inner syringe isbeing unscrewed.
 6. The adipose tissue collection and purificationdevice of claim 1, wherein the inner syringe is an inner waste chambersyringe that allows a waste product to evacuate from the lipoaspiratedtissue into a separate waste product chamber.
 7. The adipose tissuecollection and purification device of claim 1, wherein the inner syringeis a syringe of a wash fluid for washing the tissue, while back flowingthe filter to clean the filter.
 8. The adipose tissue collection andpurification device of claim 1, wherein the inner syringe is an innerwaste chamber syringe that attaches to a piston with a luer-activatedport, thus self-sealing when the waste syringe is removed so as toprevent leaking and keep the device a closed system.
 9. The adiposetissue collection and purification device of claim 1, wherein the outersyringe is added grip so as to overcome an issue of grip caused byslipperiness of the adipose tissue.
 10. The adipose tissue collectionand purification device of claim 5, wherein the non-round shaped syringeprovides extra grip to overcome an issue of grip caused by slipperinessof the adipose tissue.
 11. The adipose tissue collection andpurification device of claim 1, wherein the syringe comprises a customlocking mechanism to allow locking in the open position, therebyallowing for holding of a vacuum.
 12. The adipose tissue collection andpurification device of claim 1, wherein the syringe comprises a syringetip clogging guard added to the end of the syringe.
 13. The adiposetissue collection and purification device of claim 1, further comprisinga needle or a needle hub, wherein the needle or needle hub is attachedto the self-contained syringe device.
 14. The adipose tissue collectionand purification device of claim 1, wherein the filter material iscoated to increase stiffness so as to prevent premature filter collapse.15. The adipose tissue collection and purification device of claim 1,further comprising a guide that prevents the over insertion and underinsertion and thus allows collection of subcutaneous adipose tissue atdesired depth.
 16. The adipose tissue collection and purification deviceof claim 15, the guide is curved to allow puncture of the needle andforces the needle to remain in the subcutaneous layer of adipose tissue.17. The adipose tissue collection and purification device of claim 15,the guide further contains a mechanism that pinches the exterior of theskin and thus raises the subcutaneous fat layer to allow for insertionof the needle.
 18. The adipose tissue collection and purification deviceof claim 15, wherein the guide further contains a mechanism utilizingvacuum to raise the fat layer.
 19. A method, comprising collecting andpurifying an adipose tissue of a subject using a device, wherein thedevice comprising a self-contained syringe device comprising an innersyringe included within an outer syringe, wherein a filter is attachedinside the outer syringe barrel; wherein the filter comprises a filtermaterial, and wherein lipoaspirated adipose tissue is collected andpurified inside the syringes.
 20. The method of claim 19, wherein thefilter having a mesh pore size between 30 micro meters and 3000 micrometers.
 21. The method of claim 19, wherein the inner syringe containedwithin the outer syringe is able to evacuate the waste product fromlipoaspirated tissue into its barrel and remain contained within itsbarrel during the reinjection of remaining adipose contained within thefilter of the outer syringe.
 22. The method of claim 19, wherein theinner syringe plunger contains a one-way valve that allows for thepassage of lipoaspirate waste into its barrel but does not allow thelipoaspirate waste to re-enter the barrel of the outer syringe.
 23. Themethod of claim 19, wherein the outer syringe is non-round shaped with acorresponding non-round shaped piston such that the piston is preventedfrom rotation while the inner syringe is being unscrewed.
 24. The methodof claim 19, wherein the inner syringe is an inner waste chamber syringethat allows a waste product to evacuate from the lipoaspirated tissueinto a separate waste product chamber.
 25. The method of claim 19,wherein the inner syringe is a syringe of a wash fluid for washing thetissue, while back flowing the filter to clean the filter.
 26. Themethod of claim 19, wherein the inner syringe is an inner waste chambersyringe that attaches to a piston with a luer-activated port, thusself-sealing when the waste syringe is removed so as to prevent leakingand keep the device a closed system.
 27. The method of claim 19, whereinthe outer syringe is added grip so as to overcome an issue of gripcaused by slipperiness of the adipose tissue.
 28. The method of claim23, wherein the non-round shaped syringe provides extra grip to overcomean issue of grip caused by slipperiness of the adipose tissue.
 29. Themethod of claim 19, wherein the syringe comprises a custom lockingmechanism to allow locking in the open position, thereby allowing forholding of a vacuum.
 30. The method of claim 19, wherein the syringecomprises a syringe tip clogging guard added to the end of the syringe.31. The method of claim 19, wherein the device further comprises aneedle or a needle hub, wherein the needle or needle hub is attached tothe self-contained syringe device.
 32. The method of claim 19, whereinthe filter material is coated to increase stiffness so as to preventpremature filter collapse.
 33. The method of claim 19, wherein thedevice further comprises a guide that prevents the over insertion andunder insertion and thus allows collection of subcutaneous adiposetissue at desired depth.
 34. The method of claim 32, wherein the guideis curved to allow puncture of the needle and forces the needle toremain in the subcutaneous layer of adipose tissue.
 35. The method ofclaim 32, wherein the guide further contains a mechanism that pinchesthe exterior of the skin and thus raises the subcutaneous fat layer toallow for insertion of the needle.
 36. The method of claim 32, whereinthe guide further contains a mechanism utilizing vacuum to raise the fatlayer.